Pharma - Biotech Services

In vivo Pharmacology (Efficacy Studies)

Therapeutic areas

• Auto Immune Disorders
• Cardiovascular disorders
• CNS activity
• Dermatology
• Diabetes
• Gastrointestinal diseases
• Hypersensitivity
• Infection models
• Metabolic Disorders
• Neurology
• Oncology
• Ophthalmic diseases
• Osteoarthritis
• Pain and Inflammation
• Ulcer
• Wound Healing

DMPK

• Blood / Plasma Ratio
• Caco-2 Permeability
• CYP Induction
• CYP Inhibition Assays
• In Vitro Assays
• Microsomal Stability
• Plasma Protein Binding
• Solubility

Exploratory Toxicology

• Dose Escalation Toxicology Studies
• Dose Limiting Toxicology Studies
• Genotoxicity Screening
• Genotoxicity Screening

Genetic Toxicology

• Ames test
• Chromosomal Aberration (In Vitro / In Vivo)
• Comet Assay
• Micronucleus test (In Vitro / In Vivo)
• Mouse Lymphoma

Mammalian Toxicology

• Single Dose Studies
• Repeated Dose Studies
• Chronic Toxicology Studies
• Developmental and Reproduction Toxicology (DART)

Safety Pharmacology

• FOB / Irwin test
• HERG Assay
• Respiratory Assessment
• Telemetry

Bioassay Development and Validation

• Biomarker analysis
• Immunogenicity analysis for binding and neutralizing antidrug antibodies for therapeutic proteins and vaccines
• Measuring the intracellular activities, ADCC and CDC assays
• Pharmacodynamics
• Pharmacokinetics and toxicokinetics profiling
• Receptor binding assays

Biosimilarity Testing

• Comparative binding with receptor and with antibodies
• Functional similarity using in vitro and in vivo models
• LCMS based analysis
• Purity and contaminant levels

OECD GLP Certified and GCLP Compliant Laboratory Testing

• Preclinical toxicology
• Method development, validation and study sample analysis services for PK, PD, Biomarker and ADA assessment
• Assays validated as per US FDA, EMA and other regulatory guidance using 21 CFR compliance data acquisition instructions

In vitro Bioassays

• Assay for potency evaluation
• Functional assessment
• Measuring intracellular events
• Neutralizing antibody detection

Antibody Generation and Purification

• Antibody De Novo Sequencing
• Polyclonal antibody generation in Mice, Rat, Rabbits, Guinea pigs and in goats
• Monoclonal antibody generation by hybridoma
• Affinity purification of antisera
• Cascade immunization and null cell protein specific antibody production
• Ligand binding assay development and validation